A rapid test for the qualitative detection of IgM and IgG
antibodies to Cytomegalovirus in human whole blood, serum or plasma
The CMV IgG/IgM Rapid Test Cassette is a lateral flow
chromatographic immunoassay for the qualitative detection of IgG
and IgM antibodies to CMV in whole blood, serum or plasma to aid in
the diagnosis of CMV infection.
Cytomegalovirus is a herpes virus. It is a leading etiological
agent for congenital abnormalities and complications among those
who receive massive blood transfusions and immunosuppressive
therapy. About half of pregnant women who contract a primary
infection spread the disease to their fetus.1,2,3 Infection during pregnancy may cause mental retardation,
blindness, and/or deafness of the fetus.
The detection of anti-CMV IgM and IgG antibodies enables effective
diagnosis of acute or recent CMV infection. The CMV IgG/IgM Rapid
Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic
immunoassay for the qualitative detection of IgM antibodies to CMV
in whole blood, serum or plasma specimens.
How to use?
- Bring the pouch to room temperature before opening it. Remove the
test cassette from the sealed pouch and use it as soon as possible.
Best results will be obtained if the assay is performed within one
- Place the test cassette on a clean and level surface. Hold the
dropper vertically; draw the specimen up to the Fill Line as shown
in illustration below (approximately 10μl). Transfer the specimen
to the specimen well, then add 2 drops of buffer (approximately 80
μl) and start the timer. See the illustration below.Wait for the
colored line(s) to appear. The result should be read at 15 minutes.
Do not interpret results after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:* Two or three lines appear. One colored line should always appear in the control line region
(C) and another one or two apparent colored line(s) should be in
the test line region(s) (IgM and/or IgG).
IgM Positive: One colored should be in the control line region (C), another line
appears in IgM region. It indicates a positive test result for IgM
antibody to CMV.
IgG Positive: One colored should be in the control line region (C), another line
appears in IgG region. It indicates a positive test result for IgG
antibody to CMV.
*NOTE: The intensity of the color in the test line regions (IgM and IgG)
may vary depending on the concentration of CMV antibodies present
in the specimen. Therefore, any shade of color in the test line
region (IgM and/or IgG) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line regions (IgM and IgG).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques
are the most likely reasons for control line failure. Review the
procedure and repeat the test with a new test. If the problem
persists, discontinue using the test kit immediately and contact
your local distributor.
Internal procedural controls are included in the test. A colored
line appearing in the control region (C) is an internal positive
procedural control. It confirms sufficient specimen volume and
correct procedural technique.